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November 23, 2016

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Today's Rundown

  1. Alzheimer's hopes dashed as Lilly gives up on amyloid drug solanezumab

  2. Juno CAR-T study put on hold, again, after cerebral edemas and fatality, again

  3. Law firm that believes FDA is ‘broken’ highlights Cures Act fears

  4. Allergan chases high dose, low side effects Alzheimer’s combo in biotech buy

  5. Orchard gets $20M to trial ‘bubble boy’ gene therapy

  6. Galapagos, Gilead start phase 3 trial of filgotinib in Crohn’s

  7. Intarcia submits diabetes NDA, triggering $100M payment

Publisher's note: FierceBiotech will not be publishing Thursday, November 24, or Friday, November 25, in celebration of Thanksgiving. Keep an eye out Friday, however, for our annual "Best Of" edition highlighting the most-read stories of the year. Have a happy holiday, and as always, thank you for reading.

Featured Story

Alzheimer's hopes dashed as Lilly gives up on amyloid drug solanezumab

Eli Lilly's gamble on amyloid-busting drug solanezumab for mild Alzheimer's has failed, and the drugmaker has made the painful decision to abandon the drug.


Top Stories

Juno CAR-T study put on hold, again, after cerebral edemas and fatality, again

For the second time this year Juno has seen its midstage CAR-T Rocket trial put on hold, although this time the biotech has limited its test on its own, after two patients suffered cerebral edema earlier this week, with one dead as of last night and the other “not expected to recover.”

Law firm that believes FDA is ‘broken’ highlights Cures Act fears

We know it’s a top priority for Congress, but a group of panelists speaking at an “emergency briefing” in the U.S. Senate this week hosted by an anti-FDA legal co have urged lawmakers to not “rush a closed-door negotiated version of the bill during the lame-duck session.”

Allergan chases high-dose, low side effects Alzheimer’s combo in biotech buy

Allergan. M&A of an SME biotech. Millions of dollars involved, biobucks down the line. Seem familiar? Well, the co, still paving an independent path forward after not being subsumed by Pfizer in the spring, is at it again—this time buying out Chase Pharma in a $125 million deal.

Orchard gets $20M to trial ‘bubble boy’ gene therapy

Orchard Therapeutics has secured a $20 million grant to trial its stem cell gene therapy in patients with severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID). The funding will enable Orchard to learn whether its lentiviral approach can offer patients an alternative to GlaxoSmithKline's Strimvelis.

Galapagos, Gilead start phase 3 trial of filgotinib in Crohn’s

Galapagos and Gilead have dosed the first patient in a phase 3 Crohn’s disease trial of JAK1 inhibitor filgotinib. The initiation of the study sends the partners barreling toward pivotal data in an indication Gilead sees as a key component of its $2 billion deal with Galapagos.

Intarcia submits diabetes NDA, triggering $100M payment

Intarcia Therapeutics has filed for FDA approval of its osmotic mini-pump type 2 diabetes treatment. The submission triggered a $100 million payment, giving Intarcia some of the cash it will need to take on Big Pharma in the fiercely competitive diabetes sector should it win approval.

News of Note

Neurotrope has issued a note saying that while it is saddened by Lilly's amyloid Alzheimer's therapy failure, it believes its rival pipeline med bryostatin will still come through its tests. Release

South Korean biotech Green Cross Corporation has been given a complete response letter from the FDA for its med IVIG-SN that is seeking to treat primary immunodeficiency diseases. Statement

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